Obstructive Sleep ApneaNCT06247878
Skiin-PSG Sleep Apnea
An observational study of Obstructive Sleep Apnea, run by Myant Medical Corp. at 1 site in Canada.
Trial summary
The goal of this observational study is to develop new algorithms to detect apnea and/or hypopnea to provide additional insights to Skiin users and to their circle of care to validate and/or improve the current algorithms of the Skiin system for extraction of biological metrics during sleep based on the Skiin ECG and… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Skiin underwear chest band
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2024to 2 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study will recruit 200 individuals > 18 years old, referred to a polysomnography test due to a diagnosed or suspected obstructive sleep apnea.
Who may be able to join
- Individuals referred to do a polysomnography
- Diagnosed or suspected obstructive sleep apnea (OSA)
- 18 years old or more
- Understand and speak English enough to consent
Who cannot join
- Pregnant women
- Implanted defibrillator or pacemaker
- Absence of a garment fitting the participant's body
- An open wound or dressing (e.g. band-aid) on a body part that needs to be in contact with the Skiin electrodes
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
International Sleep Clinic WPSHC
Parry Sound, Ontario, P2A 3A4
Naheed K Hossain, naheedkhossain@jodhatishon.com
About this study
Official title: Sleep Apnea Detection and Sleep Staging Using Skiin Wearable Textile Sensors
The goal of this observational study is to develop new algorithms to detect apnea and/or hypopnea to provide additional insights to Skiin users and to their circle of care to validate and/or improve the current algorithms of the Skiin system for extraction of biological metrics during sleep based on the Skiin ECG and accelerometry data.
Read the detailed description
Eligible individuals who consent to participate will be asked to wear a Skiin Underwear chest band while going through a polyssomnography test.
- Investigational device The Skiin underwear chest band is worn at the under-chest level (under the pectoral or breast fold), and is connected to the Skiin Connected Life App (SCLA). The app collects ECG, accelerations, and temperature to generate metrics such as sleep, activity, and other physiological biometrics (resting heart rate, heart rate variability, breathing rate). The investigator will ensure the chest band is worn properly as defined by the vertical line on the band besides the Skiin logo corresponding with the center of the body.
- Polysomnography
The equipment being used for polysomnography is the Embla Sandman Elite PSG System. In advance to the test, patients receive information about the PSG test procedure and patients are usually instructed to avoid naps and stimulants (i.e., caffeine) during the day of the test. A list of instructions is usually provided to the patient.
Once the patient is ready for bed, the technologists will place sensors on the patient's scalp, temples, chest and legs using a mild adhesive, such as glue or tape. The sensors are connected by wires to a computer (wires are long enough to let the patient move around in bed). A small clip is placed on the finger or ear to monitor the level of oxygen in the blood.
Electrodes location - monitoring location includes:
- Electroencephalography (EEG) - The placement of the EEG electrodes on the scalp follows an international system known as the 10-20 system of electrode placement. This is a standardized method of identifying equally spaced electrode positions on the scalp, based on four identifiable skull landmarks.
- Electromyography (EMG) - Chin EMG records muscle tone at the mentalis and submentalis muscles. For the leg EMG two electrodes are placed about 2 to 4 cm apart longitudinally, along the belly of the anterior tibialis muscle of each leg, to record periodic limb movements.
- Electrooculography (EOG) - to record rapid eye movements of REM sleep and to assess sleep onset.
- Electrocardiography (ECG) - gel electrodes applied to the right and left subclavicular areas (essentially lead I) or the right subclavicular area and the lower left thorax (essentially lead II).
- Airflow (nasal/oral) - thermal sensors or pressure sensing
- Pulse oximetry - oximeter placed on the index finger
- Respiratory effort (thoracic/abdominal) - belts placed around the chest and abdomen to monitor movements.
- Snore sensor - small microphone
- Body position - monitoring with sensors
Bio-calibration - is a series of actions that the patient is asked to perform before initiating the PSG test. This is to ensure that the sensors are measuring what they are supposed to and to verify signal quality.
Audio-visual recording - video and audio recording is part of the clinic's standard PSG test. It allows the clinician to observe the patient's behavior during the sleep study to improve clinical interpretation and diagnosis.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Skiin underwear chest band
- Keywords
- wearable electronic devices, digital health, sleep apnea
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skiin underwear chest bandDevice
Participants will be asked to wear a skiin underwear chest band during a polysomnography test.
| Study group | Role | What they receive |
|---|---|---|
| Sleep apnea/hypopnea detection | Ability of Skiin underwear chest band in detecting sleep apnea or hypopnea will be tested against polysomnography. Receives: Device: Skiin underwear chest band |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Skiin system for detection of apnea/hypopnea compared to Polysomnography
Apnea/hypopnea events identified in the Skiin system will be compared to Apnea/hypopnea events identified in the polysomnography system. Data will be categorized as true positive, false positive, false negative to calculate the sensitivity, specificity, PPV, NPV).
Measured: Over one night, 8 to 12 hours total
Secondary outcomes (4)
Accuracy of Skiin system for detection of sleep duration compared to Polysomnography
Sleep duration recorded by the Skiin system will be compared to Sleep duration recorded by the Polysomnography system to assess accuracy. Differences, bias, and Root Mean Square Error will be calculated for each participant and for the group.
Measured: Over one night, 8 to 12 hours total
Accuracy of Skiin system for estimation of breathing rate compared to Polysomnography
Resting breathing rate calculated by the Skiin system over night will be compared to resting breathing rate calculated by the Polysomnography for accuracy check.
Differences, bias, and Root Mean Square Error will be calculated for each participant and for the group.
Measured: Over one night, 8 to 12 hours total
Accuracy of Skiin system for calculation of resting heart rate compared to Polysomnography
Resting heart rate calculated by the Skiin system over night will be compared to resting heart rate calculated by the polysomnography for accuracy check.
Differences, bias, and Root Mean Square Error will be calculated for each participant and for the group.
Measured: Over one night, 8 to 12 hours total
Accuracy of Skiin system for calculation of heart rate variability compared to polysomnography
Heart rate variability (RMSSD) calculated by the Skiin system over night will be compared to heart rate variability calculated based on the polysomnography system's data.
Differences, bias, and Root Mean Square Error will be calculated for each participant and for the group.
Measured: Over one night, 8 to 12 hours total
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start1 Feb 2024
- Primary completion1 Oct 2024 (estimated)
- Study completion2 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Myant Medical Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Jodha Tishon Inc
- Responsible party
- Sponsor
- Investigators
- Colin Shapiro, MD, Principal investigator, Jodha Tishon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06247878
- Sponsor's protocol ID
- PSG-Myant 157487
- Status last verified
- Feb 2024
- First submitted
- 9 Jan 2024
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Apnea Detection and Sleep Staging Using Skiin Wearable Textile Sensors
- ClinicalTrials.gov ID
- NCT06247878
- Acronym / sponsor ID
- PSG-Myant 157487
- Conditions
- Obstructive Sleep Apnea
- Keywords
- wearable electronic devices, digital health, sleep apnea
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Myant Medical Corp.Industry (pharma, biotech, devices)
- Collaborators
- Jodha Tishon Inc
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 2 Feb 2025 (estimated)
- First posted
- 8 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to develop new algorithms to detect apnea and/or hypopnea to provide additional insights to Skiin users and to their circle of care to validate and/or improve the current algorithms of the Skiin system for extraction of biological metrics during sleep based on the Skiin ECG and accelerometry data.
Detailed description
Eligible individuals who consent to participate will be asked to wear a Skiin Underwear chest band while going through a polyssomnography test.
- Investigational device The Skiin underwear chest band is worn at the under-chest level (under the pectoral or breast fold), and is connected to the Skiin Connected Life App (SCLA). The app collects ECG, accelerations, and temperature to generate metrics such as sleep, activity, and other physiological biometrics (resting heart rate, heart rate variability, breathing rate). The investigator will ensure the chest band is worn properly as defined by the vertical line on the band besides the Skiin logo corresponding with the center of the body.
- Polysomnography
The equipment being used for polysomnography is the Embla Sandman Elite PSG System. In advance to the test, patients receive information about the PSG test procedure and patients are usually instructed to avoid naps and stimulants (i.e., caffeine) during the day of the test. A list of instructions is usually provided to the patient.
Once the patient is ready for bed, the technologists will place sensors on the patient's scalp, temples, chest and legs using a mild adhesive, such as glue or tape. The sensors are connected by wires to a computer (wires are long enough to let the patient move around in bed). A small clip is placed on the finger or ear to monitor the level of oxygen in the blood.
Electrodes location - monitoring location includes:
- Electroencephalography (EEG) - The placement of the EEG electrodes on the scalp follows an international system known as the 10-20 system of electrode placement. This is a standardized method of identifying equally spaced electrode positions on the scalp, based on four identifiable skull landmarks.
- Electromyography (EMG) - Chin EMG records muscle tone at the mentalis and submentalis muscles. For the leg EMG two electrodes are placed about 2 to 4 cm apart longitudinally, along the belly of the anterior tibialis muscle of each leg, to record periodic limb movements.
- Electrooculography (EOG) - to record rapid eye movements of REM sleep and to assess sleep onset.
- Electrocardiography (ECG) - gel electrodes applied to the right and left subclavicular areas (essentially lead I) or the right subclavicular area and the lower left thorax (essentially lead II).
- Airflow (nasal/oral) - thermal sensors or pressure sensing
- Pulse oximetry - oximeter placed on the index finger
- Respiratory effort (thoracic/abdominal) - belts placed around the chest and abdomen to monitor movements.
- Snore sensor - small microphone
- Body position - monitoring with sensors
Bio-calibration - is a series of actions that the patient is asked to perform before initiating the PSG test. This is to ensure that the sensors are measuring what they are supposed to and to verify signal quality.
Audio-visual recording - video and audio recording is part of the clinic's standard PSG test. It allows the clinician to observe the patient's behavior during the sleep study to improve clinical interpretation and diagnosis.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sleep apnea/hypopnea detection | – | Device: Skiin underwear chest bandAbility of Skiin underwear chest band in detecting sleep apnea or hypopnea will be tested against polysomnography. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study will recruit 200 individuals > 18 years old, referred to a polysomnography test due to a diagnosed or suspected obstructive sleep apnea.
Key inclusion criteria (4 listed)
- Individuals referred to do a polysomnography
- Diagnosed or suspected obstructive sleep apnea (OSA)
- 18 years old or more
- Understand and speak English enough to consent
Key exclusion criteria (4 listed)
- Pregnant women
- Implanted defibrillator or pacemaker
- Absence of a garment fitting the participant's body
- An open wound or dressing (e.g. band-aid) on a body part that needs to be in contact with the Skiin electrodes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skiin underwear chest bandParticipants will be asked to wear a skiin underwear chest band during a polysomnography test. | Device | Sleep apnea/hypopnea detection |
Primary outcome
Accuracy of Skiin system for detection of apnea/hypopnea compared to Polysomnography
Time frame: Over one night, 8 to 12 hours total
Apnea/hypopnea events identified in the Skiin system will be compared to Apnea/hypopnea events identified in the polysomnography system. Data will be categorized as true positive, false positive, false negative to calculate the sensitivity, specificity, PPV, NPV).
4 secondary outcomes
Accuracy of Skiin system for detection of sleep duration compared to Polysomnography
Time frame: Over one night, 8 to 12 hours total
Accuracy of Skiin system for estimation of breathing rate compared to Polysomnography
Time frame: Over one night, 8 to 12 hours total
Accuracy of Skiin system for calculation of resting heart rate compared to Polysomnography
Time frame: Over one night, 8 to 12 hours total
Accuracy of Skiin system for calculation of heart rate variability compared to polysomnography
Time frame: Over one night, 8 to 12 hours total
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Colin Shapiro, MD principal investigator
Jodha Tishon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by Myant Medical Corp. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Colin Shapiro, MD (416-551-829, colinshapiro@rogers.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of Skiin system for detection of apnea/hypopnea compared to Polysomnography (time frame: Over one night, 8 to 12 hours total). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2024.